Evaluation of the Safety and Efficacy of the D.D.C Dual-control Technology Spectacle Lenses in Delaying the Progression of Myopia: a Randomized Controlled Trial

N/ANot Yet RecruitingNCT07264361

Zhongshan Ophthalmic Center, Sun Yat-sen University316 enrolled

Overview

The burden of myopia among Chinese children and adolescents is severe and trending toward younger ages, making control of myopia progression a public health priority. Current mainstream strategies include optical interventions, pharmacologic therapy, and environmental measures. Among these strategies, spectacle designs based on optical defocus-such as defocus-incorporated multiple-segment (DIMS) lenses-have demonstrated efficacy; however, the effect of such designs may attenuate over time because of "defocus adaptation." To address this limitation, D.D.C dual-control spectacles employ a densely staggered microlens layout, a gradient-defocus architecture, and an added peripheral "fogging zone" to disrupt the spatial distribution of defocus cues and reduce contrast, thereby delaying adaptation and enhancing myopia-control efficacy. The present study therefore proposes a 24-month prospective randomized controlled trial in Guangzhou, enrolling eligible myopic adolescents. The trial will first compare 12-month outcomes between D.D.C-A lenses and single-vision lenses, followed by a crossover and alternating-wear phase, to systematically evaluate the safety and efficacy of the D.D.C technology in slowing myopia progression.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

316

Conditions

Myopia, Progressive

Interventions

Eligibility

Sex: ALLMin age: 8 YearsMax age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age between 6 and 14 years; * Cycloplegic spherical equivalent refraction between -1.50 D and -5.00 D with astigmatism ≥ -1.50 D in both eyes; * Absolute interocular difference in spherical equivalent refraction ≤ 1.50 D; * Binocular best-corrected visual acuity ≥ 1.0; * Intraocular pressure between 10 and 21 mmHg in both eyes; * Volunteer to participate in this clinical trial with signature of the informed consent form. Exclusion Criteria: * History of eye injury or intraocular surgery or ocular trauma; * Clinically abnormal slit-lamp findings; * Abnormal fundus examination; * Presence of ocular diseases such as cataract, glaucoma, fundus pathology, ocular trauma, manifest strabismus, or any other condition affecting visual function; * Systemic diseases causing low immunity (such as diabetes, Down's syndrome, rheumatoid arthritis, psychotic patients or other diseases that researchers think are not suitable for wearing glasses); * Participation in a drug clinical trial within 3 months or a device clinical trial within 1 month prior to enrollment; * Participation in any myopia control clinical trial within the past 3 months and a history of myopia control interventions (e.g., orthokeratology, atropine); * Only one eye meeting the inclusion criteria; * Inability to attend regular ophthalmic examinations.